Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise

University of Sao Paulo General Hospital

Status: Completed

Conditions: Aging; Sarcopenic Obesity

Treatments: Dietary Supplement: isocaloric supplement; Dietary Supplement: Protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04981366

04234918.1.0000.0065

Details and patient eligibility

About

This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.

Full description

A major subset of adults over the age of 65 is now classified as having sarcopenic obesity, a high-risk geriatric syndrome predominantly observed in an aging population that is at risk of synergistic complications from both sarcopenia and obesity.

Lifestyle interventions such as caloric restriction and exercise training are effective nonpharmacological strategies to mitigate some adverse effects related to this condition. Also, protein supplementation may boost the benefits of exercise, but this assumption is still to be tested. This trial aims to test whether protein supplementation is able to increase the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.

Enrollment: 105 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65 years and older;
• Body mass index (BMI) > 30 kg/m2;
• Sarcopenia;
• not engage into exercise training programas.

Exclusion criteria

• cancer in the last 5 years;
• cognitive deficit or dementia that impossibility the patient to read and sign the informed consent form;
• any disease that limits participation in exercise training program.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups, including a placebo group

Control group (CTRL)

No Intervention group

Description:

Patients allocated to this arm will not receive any intervention.

Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)

Experimental group

Description:

Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation.

Treatment:

Dietary Supplement: Protein supplement

Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)

Placebo Comparator group

Description:

Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo.

Treatment:

Dietary Supplement: isocaloric supplement